Senior CQV Engineer - Validation & Commissioning

Bristol-Myers Squibb Co; Cruiserath; Sur place; EUR 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Pension contribution

Family medical allowance

27 days annual leave

Life assurance

On-site gym

Résumé du poste

Bristol Myers Squibb is seeking a permanent Senior Specialist, Engineering CQV at the Cruiserath site in Ireland. You will own qualification of process/utility equipment and validation of computerised systems from commissioning through routine operation.

You will plan risk-based protocols, maintain audit-ready validation documentation, and drive continuous improvement across MPCC and SDPF facilities, collaborating with QA, Manufacturing, Eng, MS&T and Regulatory Affairs.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry or a related field.
• Experience in equipment qualification (IQ/OQ/PQ) and/or computer systems validation (GAMP 5, 21 CFR Part 11, Annex 11).
• Strong regulatory knowledge (FDA, EMA, ICH).
• Experience with risk-based validation approaches (ICH Q9).
• Excellent problem-solving, analytical and technical writing skills.
• Strong communication and teamwork abilities.

Responsabilités

• Support commissioning, qualification and validation activities across MPCC and SDPF facilities.
• Develop CQV plans and risk-based strategies for process and utility equipment and computerised systems.
• Author, execute and report IQ, OQ and PQ protocols; provide testing support for start-up activities.
• Manage CSV deliverables (URS, FS, DS, IQ/OQ/PQ) with traceability matrices.
• Ensure compliance with 21 CFR Part 11, EU Annex 11 and data integrity requirements.
• Collaborate with QA, Manufacturing, Engineering, MS&T and Regulatory Affairs; report plans and progress.
• Identify opportunities for process improvement and enhanced compliance.
• Coach colleagues on CQV processes and procedures.

Connaissances

CQV engineering

IQ/OQ/PQ

GAMP 5

Regulatory knowledge

Problem solving

Formation

Bachelor's degree in Engineering/Life Sciences/Chemistry

Outils

Microsoft Office

Validation software tools

DeltaV

MES

SAP

Description du poste

Bristol Myers Squibb is seeking a permanent Senior Specialist, Engineering CQV at the Cruiserath site in Ireland. You will own qualification of process/utility equipment and validation of computerised systems from commissioning through routine operation.

You will plan risk-based protocols, maintain audit-ready validation documentation, and drive continuous improvement across MPCC and SDPF facilities, collaborating with QA, Manufacturing, Eng, MS&T and Regulatory Affairs.